Pharmaceutical composition as solid dosage form and method for manufacturing thereof
AssigneeFerring B.V.
InventorsHakan Lomryd, Helena Nicklasson, Lars-Erik Olsson
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Abstract
The present invention relates to a novel pharmaceutical composition as a solid dosage form comprising desmopressin as a therapeutically active ingredient, and to a method for manufacturing thereof. The invention relates to a pharmaceutical composition as a solid dosage form comprising desmopressin, or a pharmaceutically acceptable salt thereof, as a therapeutically active ingredient together with a pharmaceutically acceptable excipient, diluent or carrier, or mixture thereof; wherein the pharmaceutical composition is composed of a compressed granulate and contains lubricant in an amount of from 0.05 to less than 0.50 percent by weight of said pharmaceutical composition.
Claims55
A pharmaceutical composition as a tablet, comprising desmopressin acetate, as a therapeutically active ingredient together with a pharmaceutically acceptable excipient, diluent or carrier, or mixture thereof, wherein the pharmaceutical composition is composed of a compressed granulate and contains lubricant in an amount of from 0.05 to 0.40 percent by weight of said pharmaceutical composition, and wherein said tablet comprises from 20 to 600 μg desmopressin acetate.
A method for the manufacturing of a pharmaceutical composition as a tablet comprising desmopressin acetate as a therapeutically active ingredient, wherein said method comprises the steps of:
- i) mixing desmopressin acetate, and an excipient, diluent or carrier, or mixture thereof, optionally in the presence of a wetting agent, in an amount that provides from 20 to 600 μg of desmopressin acetate per tablet;
- ii) subjecting the resulting mixture to formation of a granulate, optionally in the presence of a wetting agent, suitable for compression into said tablet;
- iii) optionally performing said mixing and/or formation of a granulate in the presence of at least one additive selected from a disintegrating agent, binder, flavoring agent, preservative, colorant and a mixture thereof;
- iv) optionally drying said granulate;
- v) compressing said granulate into said tablet,
- wherein lubricant is introduced so that the resulting pharmaceutical composition contains lubricant in an amount of from 0.05 to 0.40 percent by weight of said pharmaceutical composition.
Dependencies are inferred from the claim text.